A phase 3 trial aiming to make chemotherapy before surgery more effective for people with locally advanced pancreatic cancer.
Research title: Evaluation of efficacy and safety of neoadjuvant treatment with Pamrevlumab in combination with chemotherapy (either Gemcitabine and Nab-paclitaxel or FOLFIRINOX) in locally advanced pancreatic cancer.
Why is this trial being carried out?
Locally advanced pancreatic cancer is cancer that has spread outside of the pancreas. It may have spread to the large blood vessels near the pancreas, or to a number of lymph nodes.
If you have locally advanced pancreatic cancer, it isn’t usually possible to remove the cancer with surgery. You may be offered chemotherapy to try to shrink the cancer or slow down its growth. For a small number of people, chemotherapy may make surgery possible.
The LAPIS trial is hoping to make chemotherapy for locally advanced cancer more effective, so there is a better chance of making surgery possible.
Pamrevlumab stops a protein called CTGF (connective tissue growth factor) working. Research has shown that CTGF plays a role in the growth and spread of pancreatic cancer cells. It is hoped that Pamrevlumab will help to make chemotherapy more effective in shrinking the cancer.
Who is the trial suitable for?
The LAPIS trial may be suitable for you if you:
- have recently been diagnosed with locally advanced pancreatic cancer
- are not able to have surgery to remove the cancer
- are well enough to take part in the trial – your doctor or nurse will talk to you about this.
The LAPIS trial may not be suitable for you if you have:
- had chemotherapy or radiotherapy to treat the pancreatic cancer
- had major surgery in the last four weeks
- had another type of cancer in the last three years, unless this was non-melanoma skin cancer or an in situ carcinoma
- taken another drug that is being researched as part of another clinical trial in the last 28 days
- an allergy or medical condition that means you can’t take part in this trial, such as an infection or heart problem – your doctor or nurse can talk to you about this.
There may be other reasons for not being able to take part in this trial. It is important to speak to your oncologist (cancer doctor) or nurse about whether this trial might be suitable for you.
What does the trial involve?
People taking part in this trial will have either:
- gemcitabine with nab-paclitaxel (Abraxane®)
- or FOLFIRNOX.
If you take part in this trial, your doctor will help you decide which is the best chemotherapy for you.
You will also have either Pamrevlumab or a placebo drug. Half of the people taking part in the trial will have Pamrevlumab, and the other half will have the placebo. This will be randomly chosen so that the treatments can be compared.
How is the treatment given?
You will have up to six cycles of treatment. Each cycle will last four weeks and include a one week break from treatment. Read more about chemotherapy cycles.
If you are having gemcitabine and nab-paclitaxel (Abraxane®), they will be given through a drip into your vein (an infusion). You will need to go to the chemotherapy day unit at the hospital once a week for three weeks to have these drugs. This should take around 2 hours each week. Read more about how gemcitabine and nab-paclitaxel are given.
If you are having FOLFIRINOX, the drugs will be given as an infusion into your vein. You will need to go to the hospital on the first and third week of each four week cycle to have this treatment. This should take around four hours each time. Read more about how FOLFIRINOX is given.
Pamrevlumab or the placebo will also be given as an infusion. This will be given at the hospital on the same days as your chemotherapy. This infusion should take around one hour.
You will have a CT scan every eight weeks to see how the treatment is working. If the cancer grows or spreads to other parts of the body, you will stop taking part in this trial. You can also stop taking part in the trial at any time if you wish.
What happens after the treatment has finished?
You will have scans and tests (such as a CT scan and PET scan) after you finish the treatment on this trial. These tests will see if you can have surgery to remove the cancer. If surgery is possible, you are likely to have it within four to eight weeks after finishing the trial treatment.
Sometimes surgery may not be possible. There are different reasons for this. For example, if the cancer can’t be removed because of how big it is or where it is, or if you are not well enough for surgery. If you can’t have surgery, you will continue to have the best treatment for you – your medical team can talk to you about your treatment options.
Recruitment start date: May 2019
Recruitment end date: December 2021
The LAPIS trial is being carried out in:
- University College London Hospital NHS Foundation Trust, London, NW1 2PG
- Imperial College Healthcare NHS Trust, London, W2 1NY
Khurum Khan and Harpreet Wasan
You can contact the trial centre: firstname.lastname@example.org
How to join a trial
Speak to your oncologist (cancer doctor) about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about this trial go to the ClinicalTrials.Gov website.
For references used to develop this information please email us.
Updated June 2021
Review date December 2021